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Trial disappointment for AZ lung cancer drug

Published on 03/10/11 at 10:45am

AstraZeneca’s lung cancer drug selumetinib has failed to hit its primary endpoint in a Phase II trial.

The trial compared selumetinib, in combination with Sanofi’s established chemotherapy drug Taxotere (docetaxel), with Taxotere alone, for the second-line treatment for a specific type of lung cancer.

The drug failed to meet its primary endpoint of increasing overall survival in the 87 patients with KRAS-mutant, locally advanced or metastatic non-small cell lung cancer (NSCLC).

This was the first completed randomised combination trial with a MEK inhibitor, but AZ will be disappointed that the drug failed to increase overall survival, the gold standard in oncology trials.

The drug did however meet its key secondary endpoints of progression-free survival, objective response rate, and alive and progression-free at six months.

Selumetinib is a small molecule MEK inhibitor that targets a key position in the Ras-Raf-MEK-ERK signaling pathway.

MEK has been shown to be frequently activated in cancer, in particular in tumours that have mutations in the Ras and Raf pathways.

The study’s results will be a setback for AZ, but the drug is currently undergoing 45 other clinical trials for various other diseases.

These include a Phase II trial, in combination with chemotherapy agent dacarbazine, that compares it with dacarbazine alone as first-line treatment of patients with melanoma whose tumours show BRAF mutations.

Ben Adams

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